FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.
The European Commission granted marketing authorization for Removab (catumaxomab), making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe.
Moffitt Cancer Center and 1ST Biotherapeutics are collaborating to accelerating innovative cancer research and clinical development.
FDA granted orphan drug designation to MB-105, March Biosciences’s first-in-class CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) from Bristol Myers Squibb for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma, based on results from the phase III CheckMate-9DW trial. The CHMP opinion will now be reviewed by the European Commission.
CHMP recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.
FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
FDA approved Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients one year of age and older with acute myeloid leukemia or myelodysplastic syndrome on Jan. 22.
Yunu and WCG announced a partnership in support of WCG’s imaging services.
